Evidence map›Paper›PMID 31433669›Full record

Trial reportCephalalgia : an international journal of headache2019

Interim results of a prospective, randomized, open-label, Phase 3 study of the long-term safety and efficacy of lasmiditan for acute treatment of migraine (the GLADIATOR study).

Jan Lewis Brandes, Suzanne Klise, John H Krege, Michael Case, Rashna Khanna, Raghavendra Vasudeva, Joel Raskin, Eric M Pearlman, David Kudrow

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cephalalgia : an international journal of headache, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 5 pooled it
10.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 5 syntheses or guidelines pooled it, 98 citations in OpenAlex.

  1. Pooled it
  2. The Effect and Safety of 5-HTBioMed research international · 2021
    Pooled it
  3. Pooled it
  4. Short-term efficacy and safety of lasmiditan, a novel 5-HTThe journal of headache and pain · 2020
    Pooled it
  5. Pooled it
  6. Trial
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  10. Trial
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  12. Review
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  14. Article
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  18. The 5-HTNature reviews. Neurology · 2023
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Jan Lewis BrandesNashville Neuroscience Group, Department of Neurology, Vanderbilt University, Nashville, TN, USA.
Suzanne KliseEli Lilly and Company, Indianapolis, IN, USA.
John H KregeEli Lilly and Company, Indianapolis, IN, USA.
Michael CaseEli Lilly and Company, Indianapolis, IN, USA.
Rashna KhannaLilly UK, Windlesham, Surrey, UK.
Raghavendra VasudevaEli Lilly and Company, Indianapolis, IN, USA.
Joel RaskinEli Lilly and Company, Indianapolis, IN, USA.
Eric M PearlmanEli Lilly and Company, Indianapolis, IN, USA.
David KudrowCalifornia Medical Clinic for Headache, Santa Monica, CA, USA.
Eli Lilly (United States) · USCalifornia Medical Clinic for Headache · USVanderbilt University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo address the need for long-term lasmiditan data, the GLADIATOR study evaluated the safety (primary) and efficacy (secondary) of lasmiditan for the intermittent, acute treatment of migraine attacks for up to 1 year.

methodsIn this prospective, randomized, open-label, Phase 3 study, patients who had completed either of two single-attack studies were offered the opportunity to be randomized 1:1 to lasmiditan 100 mg or 200 mg. Patients were asked to use lasmiditan as the first treatment for each new migraine attack of at least moderate severity. Assessments occurred at baseline and at prespecified time increments up to 48 hours after each dose of study drug using an electronic diary, and safety was assessed throughout the study. Migraine Disability Assessment (MIDAS) was assessed at each visit.

resultsAs of the cut-off date for this interim analysis (6 March 2018), 1978 patients had received ≥ 1 lasmiditan dose and treated 19,058 migraine attacks. Overall, treatment-emergent adverse events (TEAEs) were similar to those in the single-attack studies and included dizziness (18.6%), somnolence (8.5%), and paresthesia (6.8%). The frequency of TEAEs generally decreased with subsequent attacks. No treatment-related serious adverse events and no cardiovascular TEAEs potentially due to vasoconstriction were observed. For both lasmiditan doses, efficacy measures were generally consistent over study quarters and treated attacks. Overall, across all treated attacks at 2 hours post-dose, pain freedom was observed in 26.9% of the attacks treated with lasmiditan 100 mg and 32.4% of the attacks treated with lasmiditan 200 mg. MIDAS total scores decreased over time.

conclusionsThe interim results of this long-term study showed intermittent lasmiditan (100 mg and 200 mg) to be generally well tolerated and efficacious for the acute treatment of migraine over a 1-year period.

Indexed as

AdolescentAdultAgedBenzamidesDose-Response Relationship, DrugFemaleHumansMaleMiddle AgedMigraine DisordersPiperidinesProspective StudiesPyridinesSerotonin Receptor AgonistsTreatment OutcomeYoung AdultBenzamideslasmiditanPiperidinesPyridinesSerotonin Receptor Agonists5-HT1F agonistditanEpisodic migraineMIDASserotonin

Identifiers

PMID31433669
PMCPMC6779019
OpenAlexW2969260382

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.